Clinical Research Task

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A Clinical Research Task is a research task that determines the safety and efficacy of clinical therapies intended to treat disease or health condition in humans.



References

2021

2017

  • (Friesen et al., 2017) ⇒ Phoebe Friesen, Lisa Kearns, Barbara Redman, and Arthur L. Caplan. (2017). “Rethinking the Belmont Report?. ” The American Journal of Bioethics, 17(7).
    • QUOTE: ... Defining research and practice as interventions aimed at knowledge and interventions aimed at well-being is incompatible with Belmont’s own principles of respecting persons, maximizing beneficence, and ensuring justice. The boundaries around what requires oversight should be defined pragmatically, so that knowledge production and benefits to all communities are maximized and harms to participants are minimized. Oversight should be required for any research or intervention involving novel, significant risks that are not part of the standard of care. This would encourage low-risk data collection during routine practice and ensure that innovative therapies are regulated and their findings disseminated. Investigators ought to be permitted to engage in low-risk or minimally risky research with minimal oversight, while regulatory mechanisms for experiments with significant risks should be kept in place. Regulation ought to be proportionate to novelty and level of risk, rather than derived from intent. ...